Recruiting

MIOX

Sponsor:

Barnes-Jewish Hospital

Code:

NCT01918046

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a single-center, prospective sample collection study. Samples will be used to establish the performance characteristics of myo-inositol oxygenase (MIOX) as an aid in the early diagnosis of acute renal injury (AKI) following cardiac surgery.

Conditions

Acute Kidney Injury

Study ID

NCT01918046

Start date

Jul, 2013

Status verified date

Aug, 2013

Completion date

Sep, 2014

Anticipated

Primary completion date

Jul, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female scheduled for cardiac surgery including placement of Left or Right ventricular assist devices, requiring cardiopulmonary bypass
2. Age greater than or equal to 18 years

Exclusion Criteria:

1. Age less than 18 years
2. Inability to obtain Informed Consent from patient or representative
3. Prisoners or other institutionalized or vulnerable individuals.
4. Participation in an interventional clinical study within the previous 30 days.
5. History of previous renal transplantation
6. Stage 4 or 5 chronic kidney disease (estimated GFR< 30 mL/min/1.73m2)
7. Known or suspected ongoing pre-operative acute renal failure due to any cause, including pre-renal, intrinsic renal or post-renal (obstructive) etiologies (as evidenced by increasing serum creatinine or oliguria pre-operatively)
8. Already receiving dialysis, in imminent need of dialysis or considered highly likely to need dialysis in the immediate post-operative period for fluid management.
9. Any known or suspected renal ischemic or nephrotoxic insult (such as cardiac arrest, intravenous contrast procedure, etc) during the 48 hrs prior to surgery.
10. Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) infection; hepatitis B virus (HBV) infection or other infectious hepatitis.
11. Pre-operative hematocrit < 25%, recent blood transfusions have been administered to maintain hematocrit > 25% or any other contraindication to obtaining the study specified blood samples.

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Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Acute Kidney Injury [ Time Frame: 10 days ]

Central Contacts and Locations

Central contacts

Locations

Barnes-Jewish Hospital

Recruiting

St.Louis, Missouri, United States, 63110

Contacts

Anitha Vijayan, MD

avijayan@dom.wustl.edu

Principal Investigator:

Joseph Gaut, MD,PhD

More Information

Sponsor

Barnes-Jewish Hospital

Last update posted

Aug 7, 2013

Last verified

Aug, 2013

Keywords

  • biomarker
  • MIOX

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Barnes-Jewish Hospital on 2013-08-07.